PainNCT04938440
Assessment of Updated Educational Materials for Instanyl®
An observational study of Pain and Cancer Pain, run by Takeda at 1 site in United States.
Trial summary
The purpose of the Instanyl study is to learn how much doctors know and understand about Instanyl® before and after they receive updated educational information, including the risks of its unapproved use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Cancer Pain
- How many people
- 536 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2022to 6 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prescribers of Instanyl® will be assessed before and after the distribution of the updated EMs.
Who may be able to join
- Specialists of any of those medical specialties targeted for the EMs as agreed with each national competent authority. The foreseen specialties include the following (subject to changes after the EM distribution plan is completed and agreed with national competent authorities):
- Oncologists and oncoradiologists
- Anaesthesiologists
- Pain management prescribers
- Palliative care prescribers
- Internal medicine prescribers
Show all 9Show fewer
- General practitioner (GPs)
- Other specialties may be locally included such as hematology. Current and potential prescribers may vary between country; thus, some countries may have modified lists of target specialties.
- Physicians who have prescribed Instanyl® in the past 12 months (pre-EM survey) or since the updated EMs (post-EM survey) and who intend to prescribe Instanyl® in the following months after each survey.
Who cannot join
- Physicians who may have a conflict of interest (that is, prescribers employed by regulatory bodies, pharmaceutical industries).
- Inactive or retired prescribers.
- Physicians who did not prescribe Instanyl® in the past 12 months (pre-EM survey) or since the updated EMs are distributed (post-EM survey) and do not foresee treating a participants with Instanyl® in the following 12 months, regardless of whether they have prescribed Instanyl® before.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Effectiveness of Updated Educational Materials on Prescribers' Knowledge and Behavior With Respect to Risks Associated With INSTANYL® Off-Label Use
The purpose of the Instanyl study is to learn how much doctors know and understand about Instanyl® before and after they receive updated educational information, including the risks of its unapproved use. In this study, the doctors will complete two surveys: one three months before they receive the updated educational information, and one about six months after they receive this information. They will answer questions about their prescribing behavior plus their knowledge of Instanyl® including any risks.
Read the detailed description
This is a non-interventional, observational, cross-sectional study of prescribers of Instanyl®.
This study will assess the prescribers' awareness of the updated EMs and changes in prescribers' knowledge and understanding of the key information contained in the updated EMs. The study will enroll approximately 259 prescribers. The first survey (pre-EM survey) will be conducted three months before the distribution of updated EMs, second survey (post-EM survey) will be conducted six months following the distribution of updated EMs.
The data will be collected, through a self-administered web-based questionnaire. All participants will be enrolled in a single observational group:
- Prescriber of Instanyl®
This multi-center study will be conducted in France, the Netherlands, and Poland. The overall duration of the study will be approximately 22 months.
- Conditions
- Pain, Cancer Pain
- Keywords
- Drug Therapy
- Medical subject headings
- Pain, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prescribers of Instanyl® | Healthcare professionals (Oncologists, oncoradiologists, anaesthesiologists, pain management prescribers, palliative care prescribers, internal medicine prescribers, general practitioners and other specialties) who are current and potential prescribers of Instanyl® will be assessed before and after the distribution of the updated EMs via web-based survey questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Prescribers With Awareness of Updated Educational Materials (EMs) Based on Post-EM Questionnaire Survey
Measured: Up to 6 months (Post-EM Survey)
Percentage of Prescribers With Change in Knowledge and Understanding of Key Safety Information Contained in Updated EMs Based on Pre-EM to Post-EM Questionnaire Survey
Measured: Up to 9 months (Pre-EM to Post-EM survey)
Percentage of Prescribers With Change in Self-Reported Behavior Prescribing Based on Pre-EM to Post-EM Questionnaire Survey
Measured: Up to 9 months (Pre-EM to Post-EM survey)
Number of Reasons for Off-label Prescription
Measured: Up to 3 months (Pre-EM survey)
Number of Prescribers With Awareness of the Profile of Patients at Risk of Misuse and Addiction
Measured: Up to 6 months (Post-EM Survey)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start18 Feb 2022
- Primary completion6 Feb 2023
- Study completion6 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 536 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938440
- Sponsor's protocol ID
- Instanyl-5002
- Status last verified
- Jul 2023
- First submitted
- 23 Jun 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness of Updated Educational Materials on Prescribers' Knowledge and Behavior With Respect to Risks Associated With INSTANYL® Off-Label Use
- ClinicalTrials.gov ID
- NCT04938440
- Acronym / sponsor ID
- Instanyl-5002
- Conditions
- Pain, Cancer Pain
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 536 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 6 Feb 2023 (actual)
- First posted
- 24 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the Instanyl study is to learn how much doctors know and understand about Instanyl® before and after they receive updated educational information, including the risks of its unapproved use. In this study, the doctors will complete two surveys: one three months before they receive the updated educational information, and one about six months after they receive this information. They will answer questions about their prescribing behavior plus their knowledge of Instanyl® including any risks.
Detailed description
This is a non-interventional, observational, cross-sectional study of prescribers of Instanyl®.
This study will assess the prescribers' awareness of the updated EMs and changes in prescribers' knowledge and understanding of the key information contained in the updated EMs. The study will enroll approximately 259 prescribers. The first survey (pre-EM survey) will be conducted three months before the distribution of updated EMs, second survey (post-EM survey) will be conducted six months following the distribution of updated EMs.
The data will be collected, through a self-administered web-based questionnaire. All participants will be enrolled in a single observational group:
- Prescriber of Instanyl®
This multi-center study will be conducted in France, the Netherlands, and Poland. The overall duration of the study will be approximately 22 months.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prescribers of Instanyl® | – | –Healthcare professionals (Oncologists, oncoradiologists, anaesthesiologists, pain management prescribers, palliative care prescribers, internal medicine prescribers, general practitioners and other specialties) who are current and potential prescribers of Instanyl® will be assessed before and after the distribution of the updated EMs via web-based survey questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prescribers of Instanyl® will be assessed before and after the distribution of the updated EMs.
Key inclusion criteria (9 listed)
- Specialists of any of those medical specialties targeted for the EMs as agreed with each national competent authority. The foreseen specialties include the following (subject to changes after the EM distribution plan is completed and agreed with national competent authorities):
- Physicians who have prescribed Instanyl® in the past 12 months (pre-EM survey) or since the updated EMs (post-EM survey) and who intend to prescribe Instanyl® in the following months after each survey.
Key exclusion criteria (3 listed)
- Physicians who may have a conflict of interest (that is, prescribers employed by regulatory bodies, pharmaceutical industries).
- Inactive or retired prescribers.
- Physicians who did not prescribe Instanyl® in the past 12 months (pre-EM survey) or since the updated EMs are distributed (post-EM survey) and do not foresee treating a participants with Instanyl® in the following 12 months, regardless of whether they have prescribed Instanyl® before.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Prescribers With Awareness of Updated Educational Materials (EMs) Based on Post-EM Questionnaire Survey
Time frame: Up to 6 months (Post-EM Survey)
Percentage of Prescribers With Change in Knowledge and Understanding of Key Safety Information Contained in Updated EMs Based on Pre-EM to Post-EM Questionnaire Survey
Time frame: Up to 9 months (Pre-EM to Post-EM survey)
Percentage of Prescribers With Change in Self-Reported Behavior Prescribing Based on Pre-EM to Post-EM Questionnaire Survey
Time frame: Up to 9 months (Pre-EM to Post-EM survey)
Number of Reasons for Off-label Prescription
Time frame: Up to 3 months (Pre-EM survey)
Number of Prescribers With Awareness of the Profile of Patients at Risk of Misuse and Addiction
Time frame: Up to 6 months (Post-EM Survey)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Cancer Pain, run by Takeda at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Prescribers With Awareness of Updated Educational Materials (EMs) Based on Post-EM Questionnaire Survey (time frame: Up to 6 months (Post-EM Survey)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.